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MitraClip System in Australia and New Zealand (MitraClipANZ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Evalve
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Evalve
ClinicalTrials.gov Identifier:
NCT01301625
First received: February 4, 2011
Last updated: March 5, 2014
Last verified: March 2014

February 4, 2011
March 5, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
  • Echocardiographic Endpoints [ Time Frame: at 12 months after implant procedure ] [ Designated as safety issue: No ]
    MR Severity Grade Regurgitant Volume Regurgitant Fraction Left Ventricle End Diastolic Volume (LVEDV) Left Ventricular End Systolic Volume (LVESV) Left Ventricular End Diastolic Dimension (LVIDd) Left Ventricular End Systolic Dimension (LVIDs) LV Ejection Fraction (LVEF) Mitral Valve Area Mitral Valve Gradient Left Atrial Volumes
  • Clinical Endpoints [ Time Frame: at 12 months after procedure ] [ Designated as safety issue: Yes ]
    Mortality NYHA Functional Class Six-Minute Walk Test (6MWT) distance QOL Assessment (Minnesota Living with Heart Failure Questionnaire) Mitral valve surgery, including reason for and type of surgery Second MitraClip device intervention, including reason for intervention Re-hospitalizations Reason for rehospitalization (i.e., heart failure, other cardiac, non-cardiac) Number of rehospitalizations Number of days rehospitalized
Same as current
Complete list of historical versions of study NCT01301625 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
MitraClip System in Australia and New Zealand
A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand

The primary objective of the MitraClip System ANZ Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.

The MitraClip System ANZ Clinical Trial is a prospective, observational, single arm, multicenter trial to evaluate the MitraClip device for the treatment of mitral regurgitation (MR). Patients will be enrolled at up to 15 investigational sites throughout Australia and New Zealand. Up to 150 patients will be enrolled. Patients will be considered enrolled when local or general anesthesia is administered for the MitraClip procedure. Patients will be followed at discharge, 30 days, 6 months, 12 months and 24 months.

Investigational sites will recruit consecutive patients who meet trial enrollment criteria. Until enrollment in the MitraClip System ANZ Clinical Trial is closed, all patients who undergo a procedure for placement of a MitraClip device at an investigational site should be enrolled in the MitraClip System ANZ Clinical Trial.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Consecutive patients eligible to receive the MitraClip implant at the designated investigational sites in Australia and New Zealand.

Mitral Regurgitation
Device: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.
Other Names:
  • MitraClip System
  • MitraClip Delivery System
  • Steerable Guide Catheter
MitraClip Implant
Eligible patients undergoing a MitraClip procedure in Australia and New Zealand
Intervention: Device: MitraClip Implant

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older.
  • MR ≥ 3+ .
  • Transseptal catheterization and femoral vein access feasible.
  • Placement of the MitraClip device on mitral leaflets feasible.
  • Mitral valve orifice area ≥ 4.0 cm2.
  • Written informed consent obtained.
  • The patient agrees to return for follow-up visits.

Exclusion Criteria:

  • Need for emergency surgery, other cardiac surgery.
  • Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.
  • Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device (VAD).
  • Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis or rheumatic disease.
  • Transesophageal echocardiography (TEE) contraindicated.
  • Known hypersensitivity or contraindication to trial or procedure medications which cannot be managed medically.
  • Currently participating in investigational drug trial or another device trial that has not yet completed the primary endpoint or that interferes with the MitraClip System ANZ Clinical Trial.
  • Pregnant or planning pregnancy within next 12 months.
Both
18 Years and older
No
Contact: Jasmine Wilson 1-650-833-4435 jasmine.wilson@abbott.com
Australia
 
NCT01301625
Protocol #M10-001
Yes
Evalve
Evalve
Abbott
Principal Investigator: David Muller, MD St Vincent's Hospital, Sydney, Australia
Study Director: Barathi Sethuraman, PhD Abbott Vascular, Menlo Park, CA
Principal Investigator: Jurgen Passage, FRACs Sir Charles Gairdner Hospital, Perth, Australia
Evalve
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP